tetano
Editor, Senior Moderator
Braz J Infect Dis. 2016 Nov 29. pii: S1413-8670(16)30548-7. doi: 10.1016/j.bjid.2016.10.003. [Epub ahead of print]
[h=1]Immunogenicity and safety of Southern Hemisphere quadrivalent inactivated influenza vaccine: a Phase III, open-label study of adults in Brazil.[/h] Zerbini CA[SUP]1[/SUP], Santos RR[SUP]2[/SUP], Nunes MJ[SUP]3[/SUP], Soni J[SUP]4[/SUP], Li P[SUP]5[/SUP], Jain VK[SUP]5[/SUP], Ofori-Anyinam O[SUP]6[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] The World Health Organization influenza forecast now includes an influenza B strain from each of the influenza B lineages (B/Yamagata and B/Victoria) for inclusion in seasonal influenza vaccines. Traditional trivalent influenza vaccines include an influenza B strain from one lineage, but because two influenza B lineages frequently co-circulate, the effectiveness of trivalent vaccines may be reduced in seasons of influenza B vaccine-mismatch. Thus, quadrivalent vaccines may potentially reduce the burden of influenza compared with trivalent vaccines. In this Phase III, open-label study, we assessed the immunogenicity and safety of Southern Hemisphere quadrivalent inactivated influenza vaccine (IIV4; Fluarix? Tetra) in Brazilian adults (NCT02369341). The primary objective was to assess hemagglutination-inhibition (HI) antibody responses against each vaccine strain 21 days after vaccination in adults (aged ≥18-60 years) and older adults (aged >60 years). Solicited adverse events (AEs) for four days post-vaccination, and unsolicited AEs and serious AEs for 21 days post-vaccination were also assessed. A total of 63 adults and 57 older adults received one dose of IIV4 at the beginning of the 2015 Southern Hemisphere influenza season. After vaccination, in adults and older adults, the HI titers fulfilled the European licensure criteria for immunogenicity. In adults, the seroprotection rates with HI titer ≥1:40 were 100% (A/H1N1), 98.4% (A/H3N2), 100% (B/Yamagata), and 100% (B/Victoria); in older adults were 94.7% (A/H1N1), 96.5% (A/H3N2), 100% (B/Yamagata), and 100% (B/Victoria). Pain was the most common solicited local AE in adults (27/62) and in older adults (13/57), and the most common solicited general AE in adults was myalgia (9/62), and in older adults were myalgia and arthralgia (both 2/57). Unsolicited AEs were reported by 11/63 adults and 10/57 older adults. The study showed that IIV4 was immunogenic and well-tolerated in Brazilian adults and older adults.
Copyright © 2016 Sociedade Brasileira de Infectologia. Published by Elsevier Editora Ltda. All rights reserved.
[h=4]KEYWORDS:[/h] Adults; Brazil; Immunogenicity; Influenza; Quadrivalent; Safety; Vaccine
PMID: 27912069 DOI: 10.1016/j.bjid.2016.10.003
[PubMed - as supplied by publisher] Free full text
[h=1]Immunogenicity and safety of Southern Hemisphere quadrivalent inactivated influenza vaccine: a Phase III, open-label study of adults in Brazil.[/h] Zerbini CA[SUP]1[/SUP], Santos RR[SUP]2[/SUP], Nunes MJ[SUP]3[/SUP], Soni J[SUP]4[/SUP], Li P[SUP]5[/SUP], Jain VK[SUP]5[/SUP], Ofori-Anyinam O[SUP]6[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] The World Health Organization influenza forecast now includes an influenza B strain from each of the influenza B lineages (B/Yamagata and B/Victoria) for inclusion in seasonal influenza vaccines. Traditional trivalent influenza vaccines include an influenza B strain from one lineage, but because two influenza B lineages frequently co-circulate, the effectiveness of trivalent vaccines may be reduced in seasons of influenza B vaccine-mismatch. Thus, quadrivalent vaccines may potentially reduce the burden of influenza compared with trivalent vaccines. In this Phase III, open-label study, we assessed the immunogenicity and safety of Southern Hemisphere quadrivalent inactivated influenza vaccine (IIV4; Fluarix? Tetra) in Brazilian adults (NCT02369341). The primary objective was to assess hemagglutination-inhibition (HI) antibody responses against each vaccine strain 21 days after vaccination in adults (aged ≥18-60 years) and older adults (aged >60 years). Solicited adverse events (AEs) for four days post-vaccination, and unsolicited AEs and serious AEs for 21 days post-vaccination were also assessed. A total of 63 adults and 57 older adults received one dose of IIV4 at the beginning of the 2015 Southern Hemisphere influenza season. After vaccination, in adults and older adults, the HI titers fulfilled the European licensure criteria for immunogenicity. In adults, the seroprotection rates with HI titer ≥1:40 were 100% (A/H1N1), 98.4% (A/H3N2), 100% (B/Yamagata), and 100% (B/Victoria); in older adults were 94.7% (A/H1N1), 96.5% (A/H3N2), 100% (B/Yamagata), and 100% (B/Victoria). Pain was the most common solicited local AE in adults (27/62) and in older adults (13/57), and the most common solicited general AE in adults was myalgia (9/62), and in older adults were myalgia and arthralgia (both 2/57). Unsolicited AEs were reported by 11/63 adults and 10/57 older adults. The study showed that IIV4 was immunogenic and well-tolerated in Brazilian adults and older adults.
Copyright © 2016 Sociedade Brasileira de Infectologia. Published by Elsevier Editora Ltda. All rights reserved.
[h=4]KEYWORDS:[/h] Adults; Brazil; Immunogenicity; Influenza; Quadrivalent; Safety; Vaccine
PMID: 27912069 DOI: 10.1016/j.bjid.2016.10.003
[PubMed - as supplied by publisher] Free full text